Spike Identification Nanobody Panel for SARS-CoV-2 Vaccine Manufacturing

The goal of the 12-month NIIMBL project is to generate a panel of RBD-specific antibodies (“nanobodies”) that can be used for identity tests in the manufacture of SARS-CoV-2 subunit vaccines.
Categories
Vaccines
Assays
Process control

Industry Need

  • From the perspective of Chemistry, Manufacturing, and Controls (CMC), COVID-19 vaccines face challenges due to the large number of SARS-CoV-2 variants of concern (VoCs) that have emerged. 
  • Specifically, reagents for analytical assays must discriminate among the closely related vaccine antigens like recombinant receptor-binding domain (RBD) subunits. 


Solution

MassBiologics and the Wadsworth Center teamed up to generate a panel of RBD-specific antibodies (“nanobodies” or VHHs) that can be used for identity tests in the manufacture of SARS-CoV-2 subunit vaccines.  


MassBiologics used yeast-display technologies to identify nanobodies specific for each RBD VoC, while Wadsworth Center evaluated the nanobodies’ suitability to function in mock identity tests with drug substances and drug products. 

Outputs/Deliverables

• GLP-grade quality SARS-CoV-2 RBD protein antigens from wild type, Beta, Delta, and Omicron variants were produced and purified at milligram quantities.

• A panel of VoC-specific VHH-IgG antibodies against SARS-CoV-2 RBD spike protein were identified and characterized for binding affinity (ELISA, BLI), SARS-CoV-2 neutralization, and epitope class.

• Developed SOPs for RBD and RBD adsorbed binding assays

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Project Lead

New York State Department of Health (Wadsworth Center)

New York State Department of Health (Wadsworth Center)

Participating Organizations

University of Massachusetts System

University of Massachusetts System